ADAPTABLE Reaches Enrollment Milestone of 5,000 Participants

Enrollment for the Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study has reached 5,000 participants. With its coordinating center based at the Duke Clinical Research Institute, the ADAPTABLE study is a large three-year pragmatic trial assessing two different doses of aspirin – 81mg and 325mg – to evaluate which dose is more effective for patients with cardiovascular disease.

“The ADAPTABLE team is excited to have reached the milestone of 5,000 patients enrolled,” said Matthew Roe, MD,  co-PI of the study. “The lessons learned from this groundbreaking trial will have a significant influence on future clinical trials that will be focused on less costly, more effective approaches for answering important clinical questions.”

Funded through a Patient-Centered Outcomes Research Institute (PCORI) award, the ADAPTABLE study is the first demonstration project to be conducted through PCORnet – the National Patient-Centered Clinical Research Network. ADAPTABLE represents the next generation of clinical trials, referred to as pragmatic trials, which leverages electronic health records to screen and enroll patients, significantly reducing the cost required to perform clinical trials.

Reaching the milestone of 5,000 enrolled participants between April 2016 and October 2017 with significantly fewer sites than traditional trials, the ADAPTABLE study has successfully demonstrated the power of the PCORnet system in enrolling patients quickly and at a lower cost to address important clinical questions.

“ADAPTABLE is pivotal for what’s possible for pragmatic clinical trials and real world evidence,” said Adrian Hernandez, MD, vice dean for clinical research, Duke University School of Medicine and co-PI of the study. 

DCRI’s Holly Robertson, Lisa Berdan, and Tyrus Rorick lead the ADAPTABLE study’s operational team.

“What makes ADAPTABLE special is that we are a patient-centered trial with patient partners who work closely with clinicians and researchers on all aspects of the trial,” said Robertson, PhD. “We are also building a patient community that fosters open communication between enrolled participants and the research team conducting the trial to break down the barriers between individuals who work in clinical trials and the people the studies are intended to help.”​

Congratulations to the ADAPTABLE team for reaching this important landmark!